Effects of Perioperative Intravenous Dexamethasone in Clinical Outcomes After Total Knee Arthroplasty in a Hispanic Population

Sponsor

University of Puerto Rico (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06042426

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

19.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy of an intravenous (IV) perioperative dexamethasone regime in the clinical outcomes after a robotic-assisted Total Knee Arthroplasty (TKA) in a Hispanic population. The study aims to propose an alternative to opioid-based pain treatment following TKA. The study hopefully validates the use of a two-dose, 8mg intravenous dexamethasone regimen for improving pain and range of motion scores in patients undergoing primary, unilateral TKA for osteoarthritis. One dose will be applied prior to incision and the other at post-operative day (POD) 1.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee	Drug: Dexamethasone Drug: Morphine Drug: Oxycodone and acetaminophen	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

Effects of Perioperative Intravenous Dexamethasone in Clinical Outcomes After Total Knee Arthroplasty in a Hispanic Population: A Randomized Controlled Trial

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients receiving intravenous dexamethasone	Drug: Dexamethasone Two 8 mg doses. One dose applied prior to incision and the other at POD1
Active Comparator: Patients receiving intravenous morphine and oral oxycodone	Drug: Morphine Morphine 0.1 mg per kg intravenous every 6 hours Drug: Oxycodone and acetaminophen 2 tabs of oral oxycodone combined with acetaminophen every 6 hours (the same pill includes both drugs)

Arm

Intervention/Treatment

Experimental: Patients receiving intravenous dexamethasone

Drug: Dexamethasone

Two 8 mg doses. One dose applied prior to incision and the other at POD1

Active Comparator: Patients receiving intravenous morphine and oral oxycodone

Drug: Morphine

Morphine 0.1 mg per kg intravenous every 6 hours

Drug: Oxycodone and acetaminophen

2 tabs of oral oxycodone combined with acetaminophen every 6 hours (the same pill includes both drugs)

Outcome Measures

Primary Outcome Measures

POD 1 Visual Analogue Scale Pain Scores [Measured at 7:00AM day after surgery]
Range: 0-10 (10 indicates highest degree of pain)
POD 2 Visual Analogue Scale Pain Scores [Measured at 7:00AM two days after surgery]
Range: 0-10 (10 indicates highest degree of pain)
POD 3 Visual Analogue Scale Pain Scores [Measured at 7:00AM three days after surgery]
Range: 0-10 (10 indicates highest degree of pain)
POD 1 Range of Motion [Measured at 7:00AM the day after surgery]
POD 2 Range of Motion [Measured at 7:00AM two days after surgery]
POD 3 Range of Motion [Measured at 7:00AM three days after surgery]

Secondary Outcome Measures

Daily Dextrose Concentration (mg/dL) [Measured at 7:00AM for 3 days after surgery]
Length of Stay [From hospital admission to the date of discharge (About 3 days)]
Measured in days

Eligibility Criteria

Criteria

Ages Eligible for Study:

24 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient with Hispanic self-identification
Primary robotic-assisted TKA for treatment of primary osteoarthritis
Age ≥ 21
Receiving seven days of inpatient rehabilitation after medical discharge
Patient with adequate glycemic control (HbA1c<7.5%)
Patients who provide written informed consent

Exclusion Criteria:

Age ≤ 21
Chronic steroid use prior to surgery
Previous allergies or adverse reactions to steroid drugs
Indications for surgery other than primary osteoarthritis
History of narcotics abuse such as opioids
Surgeries performed without robotic-assistance
Outpatient or Home rehabilitation programs after medical discharge
Requirement of revision surgery orthopaedic implants
Patients with inadequate glycemic control (HbA1c≥7.5%)
Other medical conditions, such as osteoporosis, fungal infections, glaucoma, joint infections, peptic ulcer disease which could worsen with steroid administration.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Puerto Ric-Dr. Federico Trilla Hospital	Carolina		Puerto Rico	00984

Sponsors and Collaborators

University of Puerto Rico

Investigators

Principal Investigator: Antonio M López Otero, MD, Orthopaedic Surgery Section, University of Puerto Rico Medical Sciences Campus San Juan, Puerto Rico